SenTec recalls membrane changer sets with lots 180961, 181097, and 190053 due to a 5% chance of reduced electrolyte application during membrane changes. This may affect continuous monitoring of oxygen and carbon dioxide levels in patients.
There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.
SenTec is recalling membrane changer sets that could lead to reduced electrolyte application during use, potentially affecting oxygen and carbon dioxide monitoring. This risk is small but could impact patient monitoring accuracy.
The device may apply less electrolyte than intended during membrane changes, which could lead to inaccurate oxygen and carbon dioxide readings. This risk is small (about 5%) but might cause monitoring errors in critical patient care.
Patients using the SenTec Membrane Changer Set for continuous monitoring of oxygen and carbon dioxide levels, especially in neonatal care. Adults and pediatric patients are most at risk if the device is used incorrectly.
Check for lot numbers 180961, 181097, or 190053 on the SenTec Membrane Changer Set (1 charger plus 1 insert). The product is used for continuous non-invasive monitoring of oxygen and carbon dioxide levels in patients.
Look for lot numbers 180961, 181097, or 190053 on the device packaging.
The product is safe for most uses, but there is a small risk (about 5%) of reduced electrolyte application during membrane changes, which could affect monitoring accuracy.
Check the lot number on the device. If it matches 180961, 181097, or 190053, contact SenTec for guidance.
Yes, but you should check the lot number and follow the manufacturer's instructions to ensure accurate monitoring.
We’ve drafted a message you can send SenTec to request your refund or repair — edit it as you like.
Subject: Recall Z-2155-2019 — SenTec SenTec Hello, I own a SenTec that is covered by recall Z-2155-2019 from SenTec. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
